Sustained release oxycodone composition with acrylic polymer and surfactant

• US 20070281016A1
• Filed: 06/06/2006
• Published: 12/06/2007
• Est. Priority Date: 06/06/2006
• Status: Abandoned Application

• Current Assignee: Endo Pharmaceuticals Incorporated (Endo International PLC)
• Original Assignee: Endo Pharmaceuticals Incorporated (Endo International PLC)
• Inventors: Kao, Huai-Hung, Chang, Sou-Chan, Zeng, Yadi, Jim, Fai
• Application Number:
  US11/447,560
• Publication Number:
  US 20070281016A1
• Time in Patent Office: Days
• US Class Current: 424/468
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 9/2013 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/2027 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Abstract

The invention is a controlled release composition comprising a therapeutic amount of an active ingredient in a controlled release matrix. The matrix comprises a combination of a pharmaceutically acceptable acrylic polymer and a metal hydroxide. The amount of surfactant, relative to a given amount of acrylic polymer, is selected for and corresponds to a predetermined release rate for said active ingredient. The compound is preferably used to provide controlled release dosage of oxycodone through a matrix of ammonio methacrylic polymer and sodium lauryl sulfate.

Claims

1. A controlled release composition comprising:

a controlled release matrix comprising;

a pharmaceutically acceptable acrylic polymer; and

a surfactant in an amount selected, relative to the amount of said acrylic polymer, for and corresponding to a pre-determined release rate for said active ingredient.

2. The composition of claim 1 wherein the ratio of said surfactant to said acrylic polymer is about 0.005-0.5 by weight.

3. The composition of claim 1 wherein the ratio of said surfactant to said acrylic polymer is about 0.02-0.2 by weight.

4. The composition of claim 1 further comprising a therapeutic amount of an active ingredient.

5. The composition of claim 4 wherein said active ingredient is substantially evenly dispersed in said controlled release matrix.

6. The composition of claim 4 wherein said active ingredient is selected from the group consisting of oxycodone, oxymorphone, morphine, hydromorphone, levorphanol, codeine, hydrocodone, oxycodone, nalorphone, naloxone, naltrexone, buprenorphine, butorphanol, nalbuphine and their pharmaceutically active salts.

7. The composition of claim 1 wherein said active ingredient is oxycodone or its pharmaceutically active salts.

8. The composition of claim 1 wherein said controlled release matrix is a non-therapeutic excipient.

9. The composition of claim 1 wherein said acrylic polymer is an ammonio methacrylate based polymer.

10. The composition of claim 1 wherein said surfactant is an anionic surfactant.

11. The composition of claim 1 wherein said surfactant is sodium lauryl sulfate.

12. The composition of claim 1 wherein said surfactant is docusate sodium.

13. The composition of claim 1 wherein said surfactant is present at about 1-5% by weight of said composition.

15. The composition of claim 13 wherein said acrylic polymer is an ammonio methacrylate based polymer.

16. The composition of claim 12 wherein said surfactant is sodium lauryl sulfate.

17. The composition of claim 12 wherein said ratio of surfactant to acrylic polymer is about 0.02-0.2.

18. The composition of claim 12 wherein said active ingredient is selected from the group consisiting of oxycodone, oxymorphone, morphine, hydromorphone, levorphanol, codeine, hydrocodone, nalorphone, naloxone, naltreone, buprenorphine, butorphanol, nalbuphine, and their pharmaceutically active salts.

19. The composition of claim 12 wherein said active ingredient is oxycodone or its pharmaceutically active salts.

21. The composition of claim 18 wherein said ratio of said sodium lauryl sulfate to said ammonio methacrylate based polymer is about 0.02-0.2 by weight.

14. A controlled release composition comprising:

a therapeutic amount of an active ingredient; and

a controlled release matrix comprising;

a pharmaceutically acceptable acrylic polymer; and

a surfactant in an amount selected for and corresponding to a pre-determined release rate of said active ingredient such that the ratio of said surfactant to said acrylic polymer is about 0.005-0.5 by weight.

20. A controlled release therapeutic composition comprising:

a therapeutic amount of oxycodone or its pharmaceutically active salts; and

a controlled release matrix comprising;

a pharmaceutically acceptable ammonio methacrylate based polymer; and

sodium lauryl sulfate in an amount selected for and corresponding to a pre-determined release rate for the oxycodone or its pharmaceutically active salts, such that the ratio of said sodium lauryl sulfate to said ammonio methacrylate based polymer is about 0.005-0.5 by weight.